Associate Director, Quality Assurance (Drug Substance/Drug Product)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Quality Assurance (Drug Substance/Drug Product) based in the United States. As an Associate Director, Quality Assurance, you’ll help oversee end-to-end GxP quality activities across drug substance and drug product manufacturing programs. You’ll provide hands-on quality leadership across late-stage development, commercial manufacturing, and product lifecycle activities. The role requires close collaboration with internal teams, contract manufacturers, laboratories, suppliers, and regulatory stakeholders. You’ll ensure quality systems, controlled documentation, manufacturing processes, and product releases remain compliant with global requirements and industry standards. You’ll also play a key role in investigations, audits, change controls, CAPAs, and regulatory submissions. This is a highly collaborative, fast-paced environment suited to a quality professional who can work independently while driving complex issues toward practical resolution.